Guidance

Report on Adverse Event (AE) reporting in digital mental health technologies (DMHTs) and the development of updates to regulatory guidance

Published 1 August 2025

Background and Context

One of the roles of the Medicines and Healthcare products Regulatory Agency (MHRA) is to perform market surveillance of medical devices on the UK market and take decisions over the marketing and supply of devices in the UK.

In 2024, the government put in place legislation to clarify and strengthen the post-market surveillance requirements for medical devices in use in Great Britain. These measures came into force on 16 June 2025 and will facilitate greater traceability of incidents and trends and allow the MHRA to act swiftly when needed, supporting better risk management and containment of safety issues and reducing harm.

The new set of regulations The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 amends the UK Medical Devices Regulations (MDR) 2002 by inserting a new Part 4A on post- market surveillance (PMS) requirements for medical devices, including in vitro diagnostic (IVD) devices and active implantable medical devices which apply in Great Britain (GB). It includes notification requirements for incidents, and preventive and corrective actions taking place after the device is first approved for the GB market. 

The regulations apply to Great Britain (England, Wales and Scotland). Medical devices placed on the market or put into service in Northern Ireland (NI) must follow the post-market surveillance rules set out in EU medical devices regulations as explained by guidance on the Regulation of devices in Northern Ireland.  

The MHRA has updated its processes and procedures to ensure that trends, patterns or signals that may reveal new risks or safety concerns are identified more efficiently. This will allow both the MHRA and the whole healthcare system to better protect patients. Updated Manufacturers Online Reporting Environment (MORE) guidance has been published detailing any changes to the submission of reports

The MHRA are working closely with industry to support adoption and smooth implementation of the new requirements.  The timing therefore of including further examples for incidents relating to digital mental health technologies (DMHTs) is pertinent as there will be greater attention on the requirements and a need for greater understanding of what manufacturer obligations are for reporting under the new requirements. 

Adverse Event Reporting in Digital Mental Health Technologies

Adverse event (AE) reporting is a critical component in the evaluation and regulation of DMHTs and critically to protect patient safety. These technologies, which include mental health apps, AI-powered assessments, and virtual reality therapy, are increasingly used to support mental health. However, the remote delivery and complex mechanisms of these interventions pose unique challenges in identifying and categorising AEs.

A study published in JMIR Mental Health highlighted the significant variation in AE reporting in trials of DMHTs. The study found that only 26% of trials reported AEs within their primary results publication, and there was a notable inconsistency in how seriousness, relatedness, and expectedness of AEs were addressed (Gomez-Bergin et al. 2023). This variation underscores the need for specific guidelines to improve AE reporting in digital mental health trials and work is ongoing to address this identified deficit in knowledge and practice.

Development of the Guidance Update

The process of developing the updated guidance was conducted by the digital mental health project team, which included input from various stakeholders during a working group meeting held in April 2025. This team comprised experts from the National Institute for Health and Care Excellence (NICE), NHS policy and clinical professionals, researchers, and individuals with lived experience. The collaborative approach ensured that the examples included in the guidance considered both clinical and real-world applications of DMHTs in context.

Importance of Updated Regulatory Guidance

The recent updates to the regulatory guidance for manufacturers on reporting adverse incidents involving software as a medical device under the vigilance system by the MHRA are crucial for several reasons:

1. Clarity for Manufacturers: The updated guidance provides clear examples of serious incidents that could occur with the use of DMHTs. This helps manufacturers understand the potential risks associated with their products and ensures they implement appropriate safety measures and report serious incidents and proposed safety actions to the MHRA.
2. Enhanced Safety for Users: By including specific examples of serious incidents, the guidance helps safeguard users by ensuring that manufacturers are aware of and can mitigate these risks. This leads to more reliable and effective mental health technologies.
3. Regulatory Compliance: Recently published MHRA guidance clarifies when a DMHT is considered software as a medical device (SaMD) under UK law and how regulatory classification is determined. Clear guidance ensures that manufacturers comply with medical device regulations. Compliance is essential for market approval, user trust and places an obligation on manufacturers of SaMD to report serious incidents associated with the use of their devices. These reports can be subsequently reviewed independently by the MHRA providing an additional layer of scrutiny and oversight of the post-market performance and safety of regulated devices.

Examples from the Updated MHRA Guidance

The updated MHRA guidance includes several examples of serious incidents that could occur with DMHTs. These examples help manufacturers and stakeholders understand the types of risks that need to be addressed. For instance, the guidance highlights incidents such as incorrect AI-powered assessments leading to misdiagnosis or inappropriate treatment interventions being offered, or technical failures in virtual reality therapy causing adverse psychological effects. Further context is provided as follows for some of these use cases.

• AI Therapy Chatbots AI-powered therapy chatbots, while offering low-cost and accessible mental health support, can introduce biases and failures that result in dangerous consequences. Chatbots might contribute to harmful stigma and dangerous responses, such as enabling suicidal thoughts or delusions.
• Technical Failures in Virtual Reality Therapy Virtual reality (VR) therapy is used to treat various mental health conditions, but technical failures can lead to adverse psychological effects. For example, a malfunction in the VR system could cause disorientation, anxiety, or even exacerbate the symptoms being treated.
• Incorrect AI Assessments AI-powered assessments are used to diagnose and monitor mental health conditions. However, incorrect assessments can lead to misdiagnosis and inappropriate treatment.

Reporting these AEs to the MHRA ensures independent scrutiny and ensures the implementation and oversight of mitigating actions to resolve issues affecting the safety of the public.

Summary

In conclusion, the updated regulatory guidance by the MHRA is a significant step forward in ensuring the safety and effectiveness of DMHTs. By providing clear examples of serious incidents and involving a diverse group of stakeholders in the development process, the guidance helps manufacturers and stakeholders navigate the regulatory landscape and ultimately protect users.

References

Gómez Bergin A.D, Valentine A.Z, Rennick-Egglestone S, Slade M, Hollis C, Hall C.L.
Identifying and Categorizing Adverse Events in Trials of Digital Mental Health Interventions: Narrative Scoping Review of Trials in the International Standard Randomized Controlled Trial Number Registry JMIR Mental Health (2023) Vol.10. (Accessed 24 June 2025)